Quality Assurance

Location: Philadelphia, New York, New Jersey, DC area

Job Description

Quality Assurance (QA) Specialists support efforts and deliverables related to systems and processes to establish and ensure compliance. This involves all regulated systems through their life cycle including planning, requirements, specification, design, test, install and verification. Duties include:
  • Prepare and review SOPs and other documents for compliance and provide guidance and counsel to staff as needed.
  • Evaluate processes , propose solutions resolve issues and communicate results to support project/task completion.
  • Develop and complete deliverables related to QA activities as needed to ensure objectives are met.


Qualifications

  • College degree in technical discipline or equivalent work experience and minimum of three years of QA experience in an FDA related regulatory environment is needed.
  • Strong organization, communication and interpersonal skills to effectively work in a fast-paced team-based environment.
  • In-depth understanding of 21CFR Part 11 and other FDA regulations/guidance for clinical software.
  • Proficiency using computer software and systems related to performing QA activities.